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NCT Number: NCT07534488

Sacral Erector Spinae Plane Block in Pilonidal Sinus Surgery

This study aims to evaluate the efficacy of ultrasound-guided Sacral Erector Spinae Plane (ESP) block for postoperative analgesia management in patients undergoing pilonidal sinus surgery under general anesthesia

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Key information

Conditions

Sacral Erector Spinae Plane Block Cysts Neoplasms Pilonidal Sinus

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Medipol University

Istanbul, Turkey (Türkiye)

Location status: Recruiting

Location contact

Burak Ömür

CONTACT

[email protected]

+905056215056

About this study

Severe pain after pilonidal sinus surgery is a significant problem that reduces patient comfort. In this randomized, prospective study, patients will be divided into two groups (Sacral ESPB group and control group) using a computer randomization method before the surgery. In the Sacral ESPB group, the block will be performed under ultrasound guidance using a 20 ml local anesthetic volume immediately after the surgical procedure and before extubation. The study will compare postoperative rescue analgesic requirement, opioid consumption, pain scores (NRS), and the incidence of side effects and complications

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients scheduled for elective pilonidal sinus surgery.
  • ASA physical status I and II

Exclusion criteria

  • Allergy or sensitivity to local anesthetics or opioid drugs.
  • Infection at the block site.
  • Alcohol or drug addiction.
  • Use of anticoagulant agents.
  • Patient refusal.

Treatment and study plan

Sacral Erector Spinae Plane Block

Procedure

Immediately after the surgical procedure and before extubation, ultrasound-guided (Vivid Q) Sacral ESPB will be applied to the patient in the prone position using a total volume of 20 ml.

Standard Postoperative Analgesia

Drug

No block will be applied to this group. Both groups will receive intravenous 400 mg ibuprofen and 100 mg tramadol 20 minutes before the end of the surgery, and routine 1000 mg paracetamol every 8 hours postoperatively

Primary outcomes

  1. Total postoperative rescue analgesic (opioid) consumption.

    Time frame: At 24 hours postoperatively (Cumulative total over the 24-hour period)

    Total amount of intravenous tramadol administered as a rescue analgesic will be recorded

Secondary outcomes

  1. Postoperative pain scores evaluated by the Numeric Rating Scale (NRS)

    Time frame: At 1, 3, 6, 12, 18, and 24 hours postoperatively.

    Pain scores will be evaluated at rest and during movement using a 0-10 NRS (0= no pain, 10= most severe pain).

  2. Incidence of opioid-related side effects and block-related complications.

    Time frame: During the 24-hour postoperative period.

    Occurrence of side effects such as nausea, vomiting, itching, allergic reactions, and complications like hematoma will be recorded.

Sponsors and collaborators

Lead sponsor

Medipol University

Other

Registry information

Official study title

Evaluation of the Efficacy of Ultrasound-Guided Sacral Erector Spinae Plane Block in Postoperative Analgesia Management in Patients Undergoing Pilonidal Sinus Surgery

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 16, 2026
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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